System and method for pharmacy validation and inspection

ABSTRACT

An apparatus for verifying the identity of a dispensed pharmaceutical comprises an analysis unit adapted to determine a property of the dispensed pharmaceutical, an input device adapted to receive predetermined identifying information corresponding to the dispensed pharmaceutical, and a comparison unit adapted to compare the determined property of the dispensed pharmaceutical with the predetermined identifying information. In addition, a method of verifying a prescription, wherein the prescription comprises a pharmaceutical compound, comprises associating the prescription with a unique identifier, storing the unique identifier, determining the identity of the pharmaceutical compound, and comparing the identity of the pharmaceutical compound with the unique identifier.

This application is a continuation application of Application Ser. No.10/097,530 filed Mar. 12, 2002, now U.S. Pat. No. 6,771,369, the entirecontent of which is hereby incorporated by reference.

FIELD OF THE INVENTION

The present invention pertains to spectrometer and reflectance dataanalysis and more particularly to the validation and identification ofpackaged pharmaceuticals in a retail setting.

BACKGROUND OF THE INVENTION

There is an ongoing and predicted long-term shortage of licensedpharmacists. Due to the increasing age of the population and theever-increasing number of prescription medicines available, the demandfor prescription drugs is growing at rate that will far exceed thecapacity and numbers of licensed pharmacists. According to the NationalAssociation of Chain Drug Stores, the number of prescriptions filledbetween 2000 and 2005 will increase by 41%, while the number of retailpharmacists will only increase by 4.5%. The net impact of this imbalanceis that pharmacists are increasingly spending more time doing clericaland administrative tasks such as verifying filled prescriptions andchecking data entry done by pharmacy technicians. Since the capacity ofany one pharmacist is fixed, the output of a pharmacy has becomeconstrained. Consequently, the labor and total cost per prescriptioncontinues to rise. The December 2000 Department of Health and HumanServices Report to Congress titled “The Pharmacist Workforce: A Study ofthe Supply and Demand for Pharmacists”, which is hereby incorporated byreference into the present application, provides an overview of theabove problem.

Due to these increased demands on a pharmacist's time, and the resultingincreased reliance on technicians and other non-professional staff tofill prescriptions, there is an increased chance for prescription error.While these errors may take many forms, the likelihood of a dangerous orlife threatening “adverse drug event” increases proportionally with theincreased chance of prescription fill error. Several studies have shownthat prescription error rates are consistently in the 2% to 7% range,with a 4% error rate often cited as a reliable average. The number ofdeaths due to medication errors is estimated to exceed 7000 per year inthe United States alone. This number does not include non-fatalconditions from drugs that also result in some form of trauma or injury.The resulting litigation costs associated with these prescription fillerrors has also dramatically increased. Available information shows thatsettlements from such lawsuits average $500,000 per incident. A knownstudy on this subject is the 1999 Institute of Medicine Report: “To Erris Human: Building a Safer Heath System”, the details of which arehereby incorporated by reference into the present application.

Existing pharmacy filling systems and procedures still require a humanoperator, whether that operator is a technician or a licensedpharmacist, to validate visually whether the drug that is delivered tothe customer is correct. Thus, the human factor contributes to themajority of prescription fill errors. Existing visual verificationtechniques rely on comparing an electronic image of the prescribedmedication, i.e. a picture of the prescribed medication retrieved from adata library, with the actual medication that is dispensed for thepatient. Other systems and procedures rely on comparing the dispensedmedication with that in the original manufacturer's supply container, orcomparing an electronic image of the filled prescription with anelectronic image of the prescribed medication retrieved from a datalibrary. Each of these existing verification systems present similarproblems.

First, these known verification methods assume that all drugs arevisually distinct. This assumption causes many problems because manydrugs are not, in fact, visually distinct and, in other cases, thevisual differences between drugs is very subtle. For instance,manufacturers are rapidly running out of unique shapes, colors and sizesfor their solid dosage form products. To further complicate the problem,generic drug manufactures are using shapes, colors, and sizes that aredifferent than that of the original manufacturer.

Second, even though some known systems may utilize a National Drug Code(NDC) bar code to verify that the supply bottle being accessedcorresponds correctly to the patient's prescription, a fraction offilled prescriptions that are never picked up are returned to the supplyshelves for reuse in later prescriptions. These reused bottles will not,therefore, have a manufacturer's bar code on them. It is, therefore,impossible to incorporate such validation schemes for these unusedprescriptions. Furthermore, in these circumstances, a supply bottle isnot available for a visual comparison with the filled prescription.

Finally, each of these known manual verification and validationtechniques requires that the pharmacist spend a significant portion ofhis day performing these administrative or clerical tasks and allowsless time for patient consultation and other professional pharmacistactivities. This fact in itself is considered one of the leading reasonsfor the decline in graduation rate of professional pharmacists. Theability to allow the pharmacist to focus more on patient counselingrather than clerical and administrative duties is widely seen as animportant promotional effort to meet the increasing demand forprofessionally trained pharmacists. Similarly, personal service by apharmacist is cited in the 2001 Chain Pharmacy Industry Profile as oneof the main reasons that a customer will choose any particular pharmacy.

Solid dosage pharmaceuticals (e.g. pills, tablets, and capsules) eachhave a unique chemical composition associated with them. This is oftenreferred to as a chemical signature or fingerprint. Pharmaceuticals withvarying dosage levels of the same active ingredient may have uniquechemical signatures as well. Even slight variations in the activeingredient will produce a unique chemical signature. In that regard,most pharmaceuticals can be identified accurately by the use of someform of chemical analysis. This same methodology may be applied to otherforms of medication (e.g. liquids, creams, and powders).

While there are many forms of chemical analysis, Near-Infrared (NIR)spectroscopy is one of the most rapidly growing methodologies in use forproduct analysis and quality control. For instance, NIR spectroscopy isbeing increasingly used as an inspection method during the packagingprocess of pharmaceuticals or food products. More and more often, thistechnique is augmenting or even replacing previously used visioninspection systems. For example, a system that utilizes a combinedvisible and NIR spectroscopy inspection system can be used to inspect apharmaceutical product for, among other things, chemical composition,color, and dosage level.

Particularly with solid dosage pharmaceutical products, while a group orpackage of products may look identical in the visible portion of thespectrum each product may have a unique chemical signature in thenear-infrared wavelength range (800–2500 nm). Details of packaging andinspection systems that utilize NIR as an inspection technique can befound in U.S. patent applications Ser. Nos. 10/023,302, 10/023,395, and10/023,396 filed on Dec. 20, 2001 and U.S. patent application Ser. No.10/068,623 filed on Feb. 5, 2002, the details of which are herebyincorporated by reference into the present application.

What is unique about these NM spectrographic inspection and validationsystems is the completely “hands-off” approach that can be utilized, andthe reduced need for operator interaction in validating the compositionof packaged and filled pharmaceuticals. What is needed, therefore, is asystem that can utilize the unique chemical signatures of knownpharmaceuticals to validate the accuracy of the filled prescriptionthrough an NIR spectrographic or other chemical analysis technique.

More particularly, what is needed is a system that allows thereplacement of the manual verification techniques that most pharmaciesrely on today, thereby allowing verification and validation steps to beperformed automatically and consequently requiring less trained and lessexpensive supervision. What is also needed is a system that will accountfor the predicted added prescription throughput and reduced supply oftrained pharmacists that the pharmacy industry will face in the comingyears. Finally, what is needed is a system that will help reduce perprescription costs, reduce error rates in filling prescriptions,increase pharmacist productivity, reduce the time to complete aprescription order and allow pharmacists to spend more time with theircustomers and engaged in other professional responsibilities.

SUMMARY OF THE INVENTION

In one aspect, an apparatus for verifying the identity of a dispensedpharmaceutical comprises an analysis unit adapted to determine aproperty of the dispensed pharmaceutical, an input device adapted toreceive predetermined identifying information corresponding to thedispensed pharmaceutical, and a comparison unit adapted to compare thedetermined property of the dispensed pharmaceutical with thepredetermined identifying information.

In another aspect, a method of verifying a prescription, wherein theprescription comprises a pharmaceutical compound, comprises associatingthe prescription with a unique identifier, storing the uniqueidentifier, determining the identity of the pharmaceutical compound, andcomparing the identity of the pharmaceutical compound with the uniqueidentifier.

In another aspect, a method of adapting an existing pharmacy informationsystem to perform verification of a dispensed pharmaceutical comprisesproviding an analysis unit adapted to measure a property of thedispensed pharmaceutical, providing an input device adapted to receivepredetermined identifying information corresponding to the dispensedpharmaceutical, and providing a comparison unit adapted to compare themeasured property of the dispensed pharmaceutical with the predeterminedidentifying information.

In another aspect, A inspection system for verifying the contents of afilled prescription, comprises a spectrometer adapted to determine thespectral signature of the contents of the filled prescription, a scanneradapted to receive identifying information corresponding to the filledprescription, a data storage device coupled to the scanner and adaptedto store the identifying information corresponding to the filledprescription, wherein the data storage device comprises a plurality ofdata items, each of the plurality of data items corresponding to a knownprescription pharmaceutical spectral signature.

In another aspect, a method of filling a prescription, comprisesreceiving a prescription request, entering the prescription request intoan information system, dispensing the prescription from a supply sourceinto a customer container, applying an identification label on thecustomer container, wherein the identification label containsidentifying information corresponding to the prescription, storing theidentifying information corresponding to the prescription, determiningthe identity of the prescription, and comparing the identity of theprescription to the identifying information.

As will become apparent to those skilled in the art, numerous otherembodiments and aspects will become evident hereinafter from thefollowing descriptions and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate both the design and utility of the preferredembodiments of the present invention, wherein:

FIG. 1 is a flow chart depicting a known pharmacy filling andverification process;

FIG. 2 is a flow chart showing a pharmacy filling and verificationprocess in accordance with an aspect of the present invention;

FIG. 3 is a detailed flow chart of the chemical verification process inaccordance with an aspect of the present invention;

FIG. 4 is an embodiment of a chemical analysis and verification systemin accordance with an aspect of the present invention;

FIG. 5 is a detailed diagram of the main housing of a chemical analysisand verification system in accordance with an aspect of the presentinvention;

FIG. 6 is a detailed diagram of the spectrometer and telescope assemblyof a chemical analysis and verification system in accordance with anaspect of the present invention; and

FIG. 7 is a top view of a filled prescription vial as it is seen by achemical analysis and verification system in accordance with an aspectof the present invention.

DETAILED DESCRIPTION

Approximately 90% of the most commonly prescribed and dispensedsolid-dosage pharmaceuticals can be identified through an NIR or otherspectroscopic technique with 100% accuracy. By comparing the “chemicalsignature” of a dispensed or filled prescription to an electronicdatabase of known formulations, there can be near 100% assurance that adispensed drug is correct in both type and concentration.

FIG. 1 shows a workflow and validation process 100 that is typical forknown pharmacies and their associated prescription filling procedures.While this example is based on the filling of a solid dosageprescription, similar procedures are utilized for other dosage forms. Inthe workflow 100 shown in FIG. 1, 100% of the drugs stocked by apharmacy and filled for a patient follow the same path. In the flowdiagram 100, the bracketed text to the left indicates the pharmacypersonnel that would typically perform the corresponding task. To beginthe prescription filling process, a customer drops off or calls in anorder at 110. The order consists of one or more new or refillprescriptions. The prescription(s) are entered into the pharmacy'sinformation system at 120. As indicated, step 120 is typically performedby a technician or other administrative staff, although it may beperformed by a pharmacist as well. After the order has been entered intothe pharmacy information system, a pharmacist verifies that theprescription has been entered into the pharmacy information systemcorrectly at 130. Step 130 is typically performed by comparing theinformation entered into the pharmacy information system with theinformation contained on the written prescription. Some systems actuallyscan the written prescription into the pharmacy information systems sothat a side by side comparison can be made on a computer screen of animage of the written prescription prepared by a physician and the dataentered by the technician at step 120. Once the entered prescription isverified at 130, the filling process begins. A technician fills theprescription at 140. Some known systems utilize bar codes to ensure thatthe correct supply bottle has been selected by the technician. Allmanufacturer supply bottles include a bar coded identification numberthat contains information unique to the product and manufacturer. Othertasks that are typically performed at step 140 include assigning a tote(customer container to hold multiple prescriptions for the samecustomer) to the order, scanning the supply bottle, counting tablets andfilling the vials, printing labels and applying the label to the vial,and closing the vial and placing it in the assigned tote. Furtherdetails of these visual pharmacy inspection and verification systems canbe found in U.S. Pat. Nos. 5,597,995, 6,176,392, and 6,202,923, thedetails of which are hereby incorporated by reference into the presentapplication.

After the order has been filed at 140, the pharmacist must verify thecontents and accuracy of the filled order at 150. Since the pharmacistis ultimately responsible for the accuracy of the filled order, thistask is usually not assigned to a technician or other clerical employee.While the verification step 150 can be performed in several differentways, all existing pharmacy systems utilize a visual verificationprocess that is carried out by a professional pharmacist. FIG. 1includes several examples (150-1, 150-2, and 150-3) of how this visualverification process is normally handled.

At 150-1 a pharmacist compares the contents of the filled customer vialwith the supply bottle that was used to fill the prescription. In thecase of 150-1, the supply bottle is often left in the customer tote withthe filled vial for the pharmacist to use in verifying the vial'scontents. This is, in effect, a tablet-to-tablet comparison.Alternately, at 150-2 the pharmacist compares the contents of the filledvial to an image of the prescribed drug that is retrieved from adatabase displayed on a computer monitor for the pharmacist to view.This is a tablet-to-image comparison. Alternately, at 150-3 thepharmacist compares an electronic image taken of the filled vials with adatabase image of the same prescribed drug. This is an image-to-imagecomparison. Certain automated prescription filling systems utilize theseimage-based verification schemes by taking an image of the filled vialbefore it is released to the pharmacist for verification. Finally, at160 the order is placed with the appropriate paperwork in a pickup areafor the customer to receive the prescription.

As explained above, these known pharmacy systems all suffer from thesame general problems in that they rely on a visual verificationperformed by a human operator to validate that the prescription has beenproperly filled. The result is that a significant number ofprescriptions are incorrectly filled. Additionally, the pharmacist, whois ultimately responsible for the accuracy of the filled prescription,spends a significant portion of his or her day performing theseverifications. These and other known pharmacy inspection systems aremore fully described in U.S. Pat. Nos. 5,597,995, 6,176,392, and6,202,923, the details of which have previously been incorporated byreference into the present application.

In accordance with an aspect of the present invention, an inspectionsystem is provided that preferably replaces the visual verificationsteps associated with traditional and known pharmacy systems.Alternatively, an inspection system constructed in accordance with thepresent invention can augment existing visual verification systems. Inaddition, an inspection system constructed in accordance with thepresent invention can preferably be adapted for use with an existingpharmacy information system, or can be utilized as a stand alone andportable unit.

FIG. 2 illustrates a work flow 200 associated with one aspect of apharmacy inspection and validation system constructed in accordance withthe present invention. While this example is based on the filling of asolid dosage prescription, similar procedures may be utilized for otherdosage forms. A customer drops off or otherwise communicates aprescription to the pharmacy at 210. At 220, the customer's prescriptionis input into the pharmacy's information system or, if the prescriptionis for a refill, the prescription is recalled from the pharmacy'sinformation system. Step 220, as in the system of FIG. 1, is typicallyperformed by a pharmacy technician, rather than by a licensedpharmacist. At 230, a pharmacist performs a verification that thecustomer prescription is properly entered into the pharmacy informationsystem. Step 230 is typically performed by comparing the informationentered into the pharmacy information system with the informationcontained on the written prescription. As in the system of FIG. 1, somesystems actually scan the written prescription into the pharmacyinformation system so that a side by side comparison can be made on acomputer screen of an image of the written prescription prepared by aphysician and the data entered by the technician at step 220. At 240,after the entered prescription is verified by the pharmacist, it isreleased for filling (typically done by a technician). The technicianthen fills the customer vial and applies the prescription label,including a bar code linked to both the prescription number and thedispensed drug's unique NDC code, to the vial. Preferably, the bar codeon the prescription label includes a prescription number that is uniqueto that specific prescription fill. For example, a refill prescriptionwill get a new prescription number and not one identical to the originalprescription. This accounts for the situation where two prescriptionsfor the same drug are being filled at the same time and allows a uniqueidentifier to be associated with the prescription in addition to themanufacturer's NDC code.

At this point, the filled vial is inserted into a chemical analysissystem. The chemical analysis and validation system is referred toherein as the RxSpec™ system. At 245, the bar code label on the filledcustomer prescription vial is read into the RxSpec™ system. The stepsperformed by the RxSpec™ system, and in general, the pharmacy chemicalanalysis and validation system, are generally shown in FIG. 2 within thedashed lines represented by reference number 300. Preferably, theRxSpec™ system utilizes visible (Vis) and near-infrared (NIR)spectroscopy to analyze and identify the contents of the filledprescription vial, however, it is contemplated that any number of othermethods or variations of NIR spectroscopy can be utilized in a pharmacysystem constructed in accordance with the present invention. Forexample, various forms of optical spectroscopy, ultra-violet & visible(UV-Vis), Ultra-violet/visible/near infrared (UV-Vis-NIR), infrared, orRaman spectroscopy may be utilized in a chemical analysis andverification system constructed in accordance with the presentinvention. Additionally, optical imaging technology can also beintegrated into a chemical analysis and verification system constructedin accordance with the present invention, such as systems that areadapted to perform optical character recognition (OCR), color analysis,or other physical (rather than chemical) property analysis andidentification.

At 310, the RxSpec™ system compares the NDC derived from the bar codescanned from the label on the customer prescription vial, to a databaseof drugs that the RxSpec™ has been formatted or otherwise calibrated tochemically identify. At this point, no chemical identification has takenplace, rather the RxSpec™ system is comparing the name and dosage of thedrug associated with the customer's prescription with a preloadeddatabase of drugs that the RxSpec™ system has been calibrated toanalyze. The database also contains a representation of the uniquechemical signatures associated with each of these calibrated drugs. Itis contemplated that this database of calibrated drugs will beperiodically updated to reflect new drugs that come on the market aswell as existing drugs that are calibrated to be recognized by theRxSpec™ system. If the customer's prescription is contained in theRxSpec™ database, then, at 320, the RxSpec™ system performs a chemicalidentification on the actual tablets, or capsules that are contained inthe customer's prescription vial. At 320 the RxSpec™ system scans theitems in the filled vial and measures the chemical signature of theitems. This actual chemical signature is then matched to a particulardrug and dosage level from the database of calibrated drugs. Thisinformation is then compared at 330 to the prescription informationtaken from the bar code label on the customer's filled prescriptionvial, which has been previously stored by the RxSpec™ system. If theresults from the RxSpec™ system match the information from the bar codeon the customer's filled prescription vial, the RxSpec™ system signalsthat the filled prescription has been verified and the technician thencloses the filled vial, finalizes the prescription, and places it into atote for customer pickup at 340. The inspection and validation stepsassociated with the RxSpec™ system are automatic and can therefore beeasily performed by a technician rather than a pharmacist.

If at step 310 it is determined that the customer's prescription is notcontained in the RxSpec™ database, and therefore not amenable tochemical verification, the RxSpec™ system signals the technician that itcan not chemically verify the customer's prescription and that anotherform of verification is necessary. At 350, an alternate verificationmeans is then employed, such as one of the visual verificationtechniques previously described in connection with FIG. 1. After thecustomer's filled prescription has been verified the prescription isfinalized, bagged, and placed in a tote for customer pickup at 360.

From experimental results, it has been determined that in the processflow of FIG. 2, approximately 90% of the drugs will be able to berecognized by the RxSpec™ system and will therefore be able to beautomatically verified and validated by chemical analysis and comparisonto the prescription's bar code information. Those drugs that are notrecognized by the RxSpec™ system will need to be visually verified asdescribed above or by a similar method. In practice, verifying aprescription using the RxSpec™ system is approximately 5 times fasterthan using a manual verification method, such as visual verification.For example, in efficiently run pharmacies, it takes approximately 25seconds to visually verify a prescription. Using the RxSpec™ system hasbeen demonstrated to take approximately 5 seconds. Furthermore, theRxSpec™ system can be run by a technician since the verification processis entirely automatic. Visual verifications, since they are subject touser error, are typically performed by a pharmacist. Large retailpharmacies filling as many as 300 prescription per day and utilizing averification system constructed in accordance with the present inventionwill realize a net result of the pharmacist having approximately 1.7hours of available time to perform other tasks such as patientconsultation or filling additional prescriptions. The RxSpec™ systemdirectly identifies the actual drug contained in the prescription vialand compares it to a pre-stored library of drug signature data. Forthose drugs that are recognized by the RxSpec™ system, this verificationis accomplished with virtually 100% accuracy. Other benefits are alsorealized by implementing the inspection and validation process of FIG.2. For instance, pharmacist job satisfaction and morale will likelyincrease as a result of reduced stress and less time performing visualverification tasks; there will be faster prescription throughput timefor those drugs verified by the RxSpec™ system; there is a reduction inovertime wages; and the use of such an automated verification systemsmay be recognized as evidence of proper prescription filling in thecontext of litigation.

FIG. 3 shows a detailed flow diagram 400 of a portion of the RxSpec™system, and more particularly, one embodiment of the automated chemicalidentification and verification process. At 410, a technician scans thebar code on a prescription vial's label using a scanner attached to theRxSpec™ system. Preferably, the scanner presents an audible tone orvisual indicator letting the user know that the label has been scannedsuccessfully. The data obtained from the bar code is sent to and storedon a data storage device such as a magnetic disk drive or a networkserver. It is contemplated that various computer hardware platforms maybe utilized in such a system such as PCDOS, WINDOWS, UNIX, LINUX, etc.Additionally, the hardware platform may be part of the pharmacy'sexisting information system.

After the data from the bar code label has been stored, the RxSpec™system determines at 420 whether the drug, as represented by the datafrom the scanned bar code label on the customer's prescription vial, isin the RxSpec™ data library, and thus recognized by the RxSpec™ system.The RxSpec™ data library, is preferably a stored database of drugformulations, dosage signatures, and their associated product names,manufacturers and other identifying information that is recognized byand calibrated to the RxSpec™ system. If the drug in the filledprescription vial is not recognized by the RxSpec™ system, then at 430,the data server sends a message to the RxSpec™ system and the technicianis notified not to proceed with a chemical scan of the filledprescription through the RxSpec™ system. The technician and the generalpharmacy information system are notified that this particular drug mustfollow a standard manual/visual verification routine as previouslydescribed in conjunction with FIG. 1.

If the drug in the filled prescription vial is recognized by the RxSpec™system, then at 440, the RxSpec™ system indicates to the technician thathe can proceed with the chemical scan. The technician then places thefilled prescription vial into the RxSpec™ system, the drug, while stillin the prescription vial, is scanned and the resulting chemicalsignature data is sent to the server or existing pharmacy informationsystem. At 450, the RxSpec™ system compares the data obtained from theprescription vial bar code to the data obtained from the chemical scanand determines whether there is a match or whether there is some form ofuser error such as the prescription vial being improperly aligned in theRxSpec™ system. If there is a user error detected, the RxSpec™ systemalerts the technician at 460 and allows the technician to rescan thedrug. If the RxSpec™ system determines that the chemical scan of thedrug and the data from the prescription vial bar code are a match, theRxSpec™ system at 470 sends a message to the technician that the drughas passed the chemical inspection and validation and that theprescription vial can be capped and the prescription completed. In thiscase, visual inspection is not necessary, although, if desired, thepharmacist can choose to also visually verify the filled prescription.If the RxSpec™ system determines that the chemical scan of the drug andthe data from the prescription vial bar code are not a match, theRxSpec™ system at 480 sends a message to the technician that the drughas failed the chemical inspection and validation process. A furthermessage may also be sent to the technician indicating that either visualverification must be completed or that the pharmacist must otherwiseintervene in the prescription filling process.

FIG. 4 shows one embodiment of an RxSpec™ system 500 constructed inaccordance with an aspect of the present invention. The RxSpec™ system500 can be formatted to function either as a stand alone unit or tointegrate into an existing pharmacy information system. Line 505 in FIG.4 defines an example of how the stand alone portion of the RxSpec™system could be incorporated into an existing pharmacy informationsystem. The portion above the line 505 would be located in the actualpharmacy within easy access of the pharmacist, while the portion belowline 505 represents an existing pharmacy information system such as anetwork server or other information system platform. As a stand aloneunit, the RxSpec™ system would preferably be linked to a PC basedcomputer or portable computer system.

The RxSpec™ system 500 includes a main housing unit 510 that containsthe chemical analysis hardware and associated electronics. Preferably,the chemical analysis hardware is an Vis-NIR-based spectrometer systemadapted for use in the RxSpec™ system. However, other chemical analysissystems are contemplated by the present invention such as various formsof optical spectroscopy, ultra-violet & visible (UV-Vis),Ultra-violet/visible/near infrared (UV-Vis-NIR), infrared, or Ramanspectroscopy. It is also envisioned that digital imagery could be usedto automatically derive information on the size, shape, and color ofsolid dosage forms. The main housing 510 includes a local display unit512 that provides a user with information such as pass/fail results,system status, power availability, and various other functionalindicators of the RxSpec™ system 500. The main housing 510 is positionedon a mounting bracket 514 so that an imaging aperture or entrance slit515 of the main housing faces a sample plate 516. The sample plate 516is adapted to receive a sample, such as a prescription vial 532, so thatthe imaging aperture 515 substantially aligns with the vial 534.Preferably a guide 538 is incorporated into the sample plate 516 toeasily and consistently align the vial 532 under the imaging aperture515.

The main housing 510 is connected to a power source 519 through a cable518 and connector 520. The main housing 510 of the RxSpec™ systempreferably receives data through two separate connections. First, themain housing 510 receives data from data storage and analysis unit 550through cable 522 and connector 524. Second, the main housing 510receives data from scanner 540 through cable 526 and connector 528. Thedata storage and analysis unit, can, as described above, be either anetwork based system connected to the main housing 510 through a 10/100BaseT Ethernet connection, or it can be a local system, such as a PC orlaptop computer connected through a serial or USB port. Various otherconnection schemes are also contemplated.

In operation, data obtained through the scanner 540 from a label 534applied to the vial 532 is compared to data obtained by chemicallyidentifying the actual product contained in the vial 532. Preferably thelabel 534 is a bar code containing the unique prescription number. Inone embodiment a spectrometer-based system shines a light beam 536 atthe product in the vial 532 and acquires the chemical signature data ofthe product. The chemical signature data and the data obtained from thebar code label 534 are both sent back to the data storage and analysisunit 550. The data storage and analysis unit 550 first queries theprescription database to determine the NDC of the drug used to fill theprescription currently being verified. The data storage and analysisunit 550 preferably contains a database of chemical fingerprintscorresponding to the drugs available in the pharmacy. The database alsoincludes the corresponding NDC, manufacture name, drug name, and otheridentifying information about the available drugs. The data storage andanalysis unit 550 is also adapted to run comparison software and otheralgorithms that automatically compare the NDC determined from the barcode label 534 and the signature of the analyzed product 534 containedin the vial 532. A message is sent from the data storage and analysisunit 550 back to the RxSpec™ system's main housing 510 alerting the userwhether the prescription being verified has passed or failed theverification process.

The data storage and analysis unit 550 can take various forms as brieflydescribed above. First, it can be part of an existing pharmacyinformation system, such as a UNIX based server where the RxSpec™signature library and comparison software reside on a storage areawithin the existing server unit. Second, the data storage and analysisunit 550 can be a stand alone computer unit such as a PC based system orlaptop computer system. In this case, the RxSpec™ chemical signaturelibrary and comparison software reside on a storage area within thestand alone unit. In that regard, the RxSpec™ system would be moreconducive to portability and could be utilized in other sites than justpharmacies such as emergency rooms and ambulance environments.

FIG. 5 shows a schematic detail of the housing 510 and, moreparticularly, one embodiment of its internal construction andinterrelation between its various components. The housing 510 as shownin FIG. 5, is configured for use with a spectrometer based analysissystem, and more particularly, a Vis-NIR spectrometer system, however,it is contemplated that other types of non-invasive chemical and/orphysical analysis systems can be incorporated into systems constructedin accordance with the present invention and as described above. Thehousing 510 generally contains six main components or modules. Analphanumeric display 512, a main electronics board 600, a focal planeboard 630, a spectrograph assembly 640, a light source 670 and atelescope 680. The arrows in FIG. 5 show one embodiment of theinter-relationship between the different components of the main housing510.

The alphanumeric display 510 is adapted to display a number of differentinformation parameters pertaining to the status of the RxSpec™ systemsuch as power on status, pass or fail results of an ongoing chemicalscreen or identification, etc. The main electronics board 600 includesthe following modules and functions: a power supply 602, lightregulation 604, data collection 606, microprocessor 608, ethernetinterface 610, scanner or bar code interface 612, and a mechanismcontrol 614. The main electronics board 600 also preferably includes theconnection ports for the power supply, the ethernet connection and aserial port for the scanner interface.

The focal plane board 630 includes the spectrometer detector andassociated electronics 632. The detector 632 interprets the reflectedlight data from a sample being analyzed and transmits it back to themain electronics board for interpretation. The detector and electronics632 can be one of many known in the spectroscopy art. In otherembodiments, the focal plane board may include an exit and entrance slitfor the spectrometer, a cut-on filter, a light source mirror, and mountsfor each of the slits and filter.

The spectrograph assembly 640 includes a detector 642, grating 644, lens646, encoder 648, motor 650, shutter 652, and scanner mechanism 654. Thelight source 670 is preferably a white light that provides a broad rangeof wavelengths and is adapted to illuminate a sample 700 that is beinganalyzed. The light source 670 may be integrated with the telescopeassembly 680. The telescope assembly 680 includes slit imaging optics682, a white reference mechanism 684, a beam rotate mechanism 686, andan auto-focus mechanism 688.

FIG. 6 shows one embodiment of elements from the spectrograph assembly640 and telescope 680 from FIG. 5, and more particularly, therelationship between the telescope and focusing elements to thespectrometer. It is contemplated that numerous other embodiments of thespectrometer and telescope can be incorporated into a pharmacyinspection system in accordance with the present invention, many ofwhich are known to those of skill in the art of spectroscopy andchemical analysis. In FIG. 6, the combined spectrometer and telescopeassembly includes a spectrometer 810 having an entrance slit 812, a pairof lenses 820 and 825, a collimated light source 830 a mirror 832, and arotating beam steering element 840. The telescope assembly is generallyreferred to as 680. The dashed line 850 represents those elements of thetelescope assembly that are adapted to move up and down in order toadjust the focal point of the system. Correct focus of the system isobtained by automatically adjusting the position of the telescopefocusing elements 850 to a position that provides the maximum signal asmeasured by the spectrometer 810. The product being inspected 700 sitsin the vial 532 and is positioned under the telescope assembly 680. Therotating beam steering element 840 is adapted to take a series ofmeasurements of the product 700. Preferably, the measurements arecollected in a circular or ring shaped pattern to ensure consistency ofthe contents of the vial.

FIG. 7 shows an image of the vial 532 filled with a product 700 that isbeing inspected. The image in FIG. 7 is how the vial 532 and product 700would appear to the telescope assembly, i.e. looking down into thefilled vial. Ring 860 represents the scanning path produced by therotating beam steering element 840 and points 865 represent a series oflocations measured by the RxSpec™. Other sampling patterns or analysisalgorithms may be incorporated into the spectrometer system inaccordance with the present invention.

Although the present invention has been described and illustrated in theabove description and drawings, it is understood that this descriptionis by example only and that numerous changes and modifications can bemade by those skilled in the art without departing from the true spiritand scope of the invention. The invention, therefore, is not to berestricted, except by the following claims and their equivalents.

1. An apparatus for verifying the identity of a dispensedpharmaceutical, comprising: an analysis unit adapted to determine aproperty of the dispensed pharmaceutical; an input device adapted toreceive predetermined identifying information corresponding to thedispensed pharmaceutical; and a comparison unit adapted to compare thedetermined property of the dispensed pharmaceutical with thepredetermined identifying information.
 2. The apparatus of claim 1,wherein the analysis unit is an optical spectroscopy system.
 3. Theapparatus of claim 1, wherein the analysis unit is a near-infraredoptical spectroscopy system.
 4. The apparatus if claim 1, wherein theanalysis unit is a visible and near-infrared optical spectroscopysystem.
 5. The apparatus of claim 1, wherein the analysis unit is aninfrared optical spectroscopy system.
 6. The apparatus of claim 1,wherein the analysis unit is an ultra violet and visible spectroscopysystem.
 7. The apparatus of claim 1, wherein the analysis unit is anultra violet, visible, and infrared spectroscopy system.
 8. Theapparatus of claim 1, wherein the analysis unit is a Raman spectroscopysystem.
 9. The apparatus of claim 1, wherein the analysis unit furthercomprises an imaging device adapted to determine a physical property ofthe dispensed pharmaceutical.
 10. The apparatus of claim 9, wherein thephysical property is size, shape, or color.
 11. The apparatus of claim9, wherein the imaging device is adapted to perform optical characterrecognition (OCR).
 12. The apparatus of claim 1, wherein the analysisunit comprises a spectrometer.
 13. The apparatus of claim 12, whereinthe analysis unit further comprises a processor; a telescope assemblycoupled to the spectrometer; and a light source.
 14. The apparatus ofclaim 1, wherein the input device is a scanner adapted to read a barcode symbol and wherein the predetermined identifying informationcorresponding to the dispensed pharmaceutical comprises a bar codesymbol.
 15. The apparatus of claim 1, wherein the predeterminedidentifying information corresponding to the dispensed pharmaceuticalincludes manufacturer information.
 16. The apparatus of claim 1, whereinthe predetermined identifying information corresponding to the dispensedpharmaceutical includes product name information.
 17. The apparatus ofclaim 1, wherein the predetermined identifying information correspondingto the dispensed pharmaceutical includes dosage level information. 18.The apparatus of claim 1, wherein the predetermined identifyinginformation corresponds to the same properties measured by the analysisunit.
 19. The apparatus of claim 14, wherein the scanner is a hand-helddevice.
 20. The apparatus of claim 14, wherein the scanner is a tabletop mounted device.
 21. The apparatus of claim 1, wherein the comparisonunit is integral with the analysis unit.
 22. The apparatus of claim 1,wherein the apparatus is adapted for use in a retail pharmacy.
 23. Theapparatus of claim 1, wherein the apparatus is adapted for use in acentral filling facility.
 24. The apparatus of claim 1, wherein theapparatus is adapted for use in automated filling systems.
 25. Theapparatus of claim 1, wherein the apparatus is adapted for use as astand alone unit.
 26. The apparatus of claim 1, wherein the apparatus isadapted for integration with an existing pharmacy information system.27. The apparatus of claim 1, wherein the dispensed pharmaceutical is asolid dosage pharmaceutical.
 28. The apparatus of claim 1, wherein thedispensed pharmaceutical is a liquid pharmaceutical.
 29. The apparatusof claim 1, further comprising a user interface.
 30. The apparatus ofclaim 1, wherein the comparison unit comprises a microprocessor capableof being programmed with an algorithm.
 31. The apparatus of claim 1,wherein the comparison unit comprises: a network database adapted tostore the predetermined identifying information corresponding to thedispensed pharmaceutical.
 32. The apparatus of claim 1, wherein theapparatus is adapted to identify unknown drugs.
 33. A method of adaptingan existing pharmacy information system to perform verification of adispensed pharmaceutical, comprising: providing an analysis unit adaptedto measure a property of the dispensed pharmaceutical; providing aninput device adapted to receive predetermined identifying informationcorresponding to the dispensed pharmaceutical; and providing acomparison unit adapted to compare the measured property of thedispensed pharmaceutical with the predetermined identifying information.34. The method of claim 33, wherein the existing pharmacy informationsystem includes a data storage device and wherein the comparison unit isincorporated into the data storage device.
 35. The method of claim 33,wherein the existing pharmacy information system comprises an automatedfilling system.
 36. The method of claim 33, wherein the existingpharmacy information system comprises a visual verification system. 37.The method of claim 33, wherein the analysis unit comprises anear-infrared spectroscopy system.
 38. The method of claim 37, whereinthe analysis unit further comprises an optical imaging system.
 39. Anapparatus for verifying the contents of a dispensed pharmaceutical,comprising: means for determining information corresponding to aproperty of the dispensed pharmaceutical; means for receivingpredetermined identifying information corresponding to the dispensedpharmaceutical; and means for comparing the determined property of thedispensed pharmaceutical with the predetermined identifying information.40. The apparatus of claim 1 wherein the analysis unit further comprisesa device adapted to determine the chemical composition of the dispensedpharmaceutical.
 41. The apparatus of claim 1 wherein the apparatus is adistributed system.
 42. The apparatus of claim 1 wherein the analysisunit, the input device, and the comparison unit are located remotelyfrom each other.
 43. A distributed system for verifying the identity ofa pharmaceutical compound, comprising: an analysis unit adapted todetermine a property of the pharmaceutical compound; an input deviceadapted to receive predetermined identifying information correspondingto the pharmaceutical compound; and a comparison unit adapted to comparethe determined property of the pharmaceutical compound with thepredetermined identifying information.
 44. The system of claim 43wherein the analysis unit is a spectroscopy system.
 45. The system ofclaim 43 wherein the analysis unit further comprises an imaging deviceadapted to determine a property of the pharmaceutical compound.